New York State Bottled and Bulk Water Program 2007 Annual Report

New York State Department of HealthBureau of Water Supply ProtectionBottled and Bulk Water Program2007 Annual Report

Purpose

The Bottled and Bulk Water Program 2007 Annual Report is a summary of those 2007 certification program activities under the purview of Section 225(u) of the Public Health Law (PBH) of the Laws of New York. The standards for bottled and bulk water facilities are contained in Subpart 5-6, Bottled and Bulk Water Standards, of the State Sanitary Code. Subpart 5-6 requires that all bottled or bulk water sold, offered for sale or delivered for human consumption, food preparation, or culinary purposes be certified by the New York State Department of Health (Department).

Certification

Initial certification of bottled and bulk water requires the submission of the following items:

In 2007, 16 bottled water facilities and 6 bulk water facilities received initial certification to sell, offer for sale or deliver for human consumption, food preparation, or culinary purposes their products in New York State. By the end of 2007, the total number of bottled and bulk water facilities certified by the Department reached 213. Of these 213 certified bottled/bulk water facilities, 68 are located in New York State, 108 are located out-of-state and 37 are located in foreign countries.

2007 Bottled and Bulk Water Certifications

Certification Type

Facility Location

Bottled Water

Bulk Haulers

Totals

Initial

Within NYS

1

1

2

Out of State (within USA)

11

5

16

Out of Country

4

0

4

Initial Certification Total

16

6

22

Renewal

Within NYS

26

40

66

Out of State (within USA)

71

21

92

Out of Country

31

2

33

Renewal of Certification Total

128

73

191

Uncertified Bottled and Bulk Water in New York State

As required under Subpart 5-6.2, "No person shall sell, offer for sale or deliver bottled or bulk water for human consumption, food preparation, or culinary purposes unless certified by the Commissioner in accordance with the requirements of this Subpart". Therefore, after the Department is notified that facilities are illegally selling and/or distributing bottled and/or bulk water in New York State, the Department requires the facility to cease their activities of selling and/or distributing their product in New York State until
they have obtained the necessary certification. Accordingly, the Department sends a letter to each uncertified bottled or bulk water facility stating that they must cease and desist from selling, offering for sale and delivering their bottled and/or bulk water in New York State as well as instruct their offices, branches and distributors to remove all the bottled water products from the New York State market.

In 2007, 22 bottled water companies were notified by the Department that they were not certified to sell, distribute, and/or offer for sale bottled water products in New York State. 5 bulk water haulers were notified by the Department that they were not certified to sell or distribute potable water in New York State and that all bulk hauling for human consumption, food preparation or culinary purposes within New York State must cease.

Decertifications

In 2007, the Department decertified 27 bottled and bulk water facilities and were instructed to withhold from selling, offering for sale or delivering bottled or bulk water in New York State, for human consumption, food preparation or culinary purposes. The majority of decertifications resulted from bottled or bulk water facilities failing to submit complete documentation in order to be eligible for recertification.

Also in 2007, the Department expanded its required public notice of certified bottled and bulk water facilities to include monthly decertification updates pursuant to Section 225(u)(vi) of the Public Health Law of the Laws of New York. The facility will appear on the top of each notice reserved for decertifications the month it becomes decertified and will be repeated on 11 successive monthly notices unless the facility becomes recertified within 12 months. After 12 months, the notice requirement has been met and the facility is dropped from all listings until such time as the facility applies for certification anew.

Distribution

In 2007, 213 certified bottled water facilities reported, that of the approximately 6,187,307,178 total gallons they produced during 2006, approximately 621,862,517 gallons were distributed to New York State. This distribution is an aggregate of several product types including but not limited to: well, spring, mineral, carbonated, distilled, deionized, drinking, and sparkling waters. In 2007, certified bulk water haulers reported that approximately 140,392,466 gallons of potable drinking water was distributed in New York State.

NOTE: 2007 production numbers will be reported in 2008.

Inspections

An annual inspection must be made of each bottled and bulk water facility. The inspection may be conducted by the New York State Department of Health, local county health department or district office, or by a third party approved by the Department. Out-of-state bottling facilities must provide certification from the appropriate regulatory agency of the state or country having jurisdiction over the bottling operation, indicating that the facility has been inspected and approved to bottle or package water for human consumption. Annual inspection of facilities consists of sampling and an evaluation of the source, bottling and treatment processes, sanitation and maintenance procedures as well as compliance with good manufacturing practices.

Monitoring

Annual Requirements

New York State certified bottled and bulk water facilities are required to monitor for organic chemical, inorganic chemical and radiological analyses, on an annual basis, for each source and finished product type. All monitoring required by Subpart 5-6 of the State Sanitary Code must be conducted by a laboratory certified by the Department's Environmental Laboratory Approval Program (ELAP).

Monthly Requirements

New York State certified bottled and bulk water facilities are required to monitor, on a monthly basis, microbiological analyses in accordance with Subpart 5-6, Section 5-6.11, Table 1A - Microbiological Sampling Frequency.

Surveillance Monitoring

Approximately 70 bottled and bulk water surveillance and/or complaint investigation samples were collected by Department (both field and central office) staff which were analyzed for either inorganic chemical, organic chemical, microbiological and/or particle identification parameters. These samples were collected primarily in response to product recalls, consumer complaints or to verify results received for initial certification of new products.

Violations

Bottled and bulk water facilities are required to submit a Monthly Operating Report (DOH-357) no later than the 10th of the month following the month of the reporting period. The required amount of monthly monitoring is determined by the number of gallons produced for New York State distribution or the number of potable water gallons hauled in New York State and is outlined in Section 5-6.11, Table 1A of Subpart 5-6 of the State Sanitary Code.

In 2007, the Department sent 21 violation letters to certified bottled water facilities and 24 violation letters to certified bulk water haulers for non-submittal of Monthly Operating Reports. Also, the Department sent 18 violation letters to certified bottled water facilities and 14 violation letters to certified bulk water haulers for non-submittal of monthly microbiological results from a New York State Health Department certified laboratory (see Monthly Violations for 2007 table below). All data were complete at time of renewal of certified bottlers.

Monthly Violations for 2007*

Certification Type

Failure to Submit MonthlyOperating Report

Failure to SubmitMicrobiological Results

Bottled Water

21

18

Bulk Water

24

14

Total

45

32

* The number of Monthly Violation letters are not reflective of actual violations for 2007 due to administrative changes in enforcement processing.

In 2007, the Department sent 13 violation letters to New York State certified bottled and bulk water facilities when monthly microbiological sample results tested positive for coliform and/or E. coli for their source or their finished products. The facilities were required to take follow-up samples, determine the source of the problem and take the necessary course of action. Also, the Department sent 33 violation letters to bottled and bulk water facilities when results of a Standard Plate Count (SPC) or Heterotrophic Plate Count (HPC) result was greater than 500 cfu/mL.

Enforcement

In 2007, the Department initiated enforcement actions against 12 bottled/bulk water facilities for violations of Subpart 5-6 of the State Sanitary Code in addition to issuing notices of violation and conducting subsequent follow-up investigations.

Product Recalls

The New York State Sanitary Code Subdivision 5-6.7(i), requires bottled water facilities have on file a written recall plan which details the procedures for recall of any particular batch as identified by the production date code. This recall plan may be initiated when it is determined (by the bottler and/or State Health Department) that a potential contamination incident has occurred.

In 2007, there were 2 incidents of contamination of bottled water products in New York State. In one instance, the Department, upon review of laboratory analyses, found that the bromate levels exceeded the federal Food and Drug Administration's (FDA) standard of quality for bromate. The Department continued to participate in the ensuing investigation with the FDA. In both cases, a recall of the products was initiated by the bottler(s) because of the potential for affecting public health due to the bromate level in the finished product.

Complaints

The Department addresses bottled/bulk water complaints based upon the nature and severity of the complaint at hand. For complaints related to distribution or financial issues, the complainant is referred to the vendor or the bottler. Complaints that suggest illness, possible water quality standard exceedances, imminent or widespread public danger will be referred for investigation to the Department which works in concert with the appropriate local county health department or district office in which the bottler is located. Complaints dealing with aesthetic concerns are addressed by either the bottling facility or the appropriate level of Health Department.

In 2007, approximately 70 consumer complaints were received and/or referred to the Department for investigation and follow-up. The majority of the consumer complaints consisted of isolated incidents involving taste and/or odor problems associated with bottled water products or household contamination of the product. In most cases, sealed bottled water products from the same production run, or as close as possible to the production run, were sent to the Department's Wadsworth Laboratory for testing.

Public Education and Outreach

In 2007, the Department's Bureau of Water Supply Protection (BWSP) fielded hundreds of telephone, e-mail and letter inquiries concerning the Bottled and Bulk Water Program. Typical inquiries included regulation questions, certification questions and complaints. These inquiries were received from consumers, media, field staff, bottlers, bulk water haulers and other state and foreign agencies. In addition, BWSP staff provided program presentations at conferences as well as for field staff training purposes.